Quality Assurance Associate (temp - onsite)
About Cerus :
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
Duration of temp assignment : 2 months.
Primary Responsibilities :
- Monitor and track quality system deliverables to completion including NC / CAPA actions, internal audit findings, supplier audits, and actions from management reviews and data reviews.
- Manage supplier documentation for production, release, and development activities.
- Review manufacturing, QC, release records, and documentation for medical device and drug substance / drug product.
- Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
- Revise SOPs / INSs, prepare flow charts and other quality documentation.
- Publish monthly supplier qualification, quality reports, and KPI trends.
- Perform other related duties as required.
Qualifications / Requirements / Skills :
- Bachelor's degree or equivalent in a scientific discipline with a minimum of 2 years' experience in a pharmaceutical or medical device industry
- Strong understanding of the FDA GMP regulations, Medical Device Directive, ICH Q7, ISO 13485, and sterilization standards.
- Strong communication skills (encompasses verbal, written, interpersonal, listening).
- High level of attention to detail and accuracy
- Ability to exercise independent judgement
- Strong organizational skills
- Time management skills (schedules, timelines, task prioritization)
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
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